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Development of a Database to Investigate Digital and Blood-Based Biomarkers and Their Relationship to Tau and Amyloid PET Imaging in Older Participants Who Are Cognitively Normal (CN), Have Mild Cognitive Impairment (MCI), or Have Mild-to-Moderate AD Dementia

Sponsor: GAP Innovations, PBC

NCT ID: NCT06584357

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Biomarker Data Collection (other), MK6240 (radiation)
How long the study runs
Study runs about 46 months (dates as stated)
About the drug or intervention
Biomarker Data Collection — other: During this study, a sample of your blood will be collected and you will have a PET scan taken of your brain. · MK6240 — radiation: Each participant will be assessed using either one of two radioactive tau PET tracers: Flortaucipir or MK6240.
Patient visit burden
Not specified by the sponsor

In plain English

This study is building a database to explore how digital tools and blood tests (biomarkers) relate to brain scans that show tau and amyloid proteins in older adults. It includes people aged 60 to 90 who are either cognitively normal, have mild cognitive impairment (MCI), or have mild-to-moderate Alzheimer's disease dementia. The sponsor is GAP Innovations, PBC.

Who can take part

  • Aged 60 to 90 years
  • Have a study partner who spends at least 8 hours a week with you and can describe your memory and daily abilities
  • Give written consent (or a legally authorised representative consents for you)
  • Willing to have a brain MRI (magnetic resonance imaging) scan within 90 days and amyloid and tau PET (positron emission tomography) scans within 120 days of consenting
  • Willing to follow all study steps, including blood samples, genetic testing, and storing samples for future research
  • Fluent in the language used for tests at the study site
  • Willing to be contacted about other research trials after this study ends
  • Mini-Mental State Exam (MMSE) score between 16 and 30 at screening

Who may not be able to

  • Unable to have amyloid and tau PET scans (for example due to pregnancy, sensitivity to the substances used, poor vein access, or too much radiation exposure)
  • Have had a negative amyloid PET scan in the past 6 months
  • Any reason you cannot have a brain MRI scan
  • Stroke or seizures within the past year
  • Cancer within the past 5 years (except non-melanoma skin cancer or prostate cancer in situ)
  • Alcohol or drug abuse or dependence within the past year
  • Unstable psychiatric symptoms, such as uncontrolled depression, that could affect the study
  • Have had a potential disease-modifying Alzheimer's treatment within the past 6 months
  • HIV positive unless controlled by antiviral medicine
  • Serious or unstable medical conditions that would stop you completing the study
  • Untreated conditions such as vitamin B12 or folate deficiency or bladder infections that could affect memory
  • Cognitive testing within 1 month before screening that could cause a practice effect
  • Other neurological disorders affecting the brain (such as Parkinson's disease, other dementias, or repeated concussions) that may affect memory
  • Geriatric Depression Scale (GDS) score of 8 or more at screening, if considered clinically significant depression
  • Rey Auditory Verbal Learning Test (RAVLT) t-score of 1.2 standard deviations or more above the mean
  • Weigh less than 110 pounds (about 50 kilograms)
  • Direct employees of the study sites or the sponsor, or their family members
  • Cannot complete memory tests due to eyesight or hearing problems
  • For the RetiSpec retinal (eye) scan: allergy or reaction to Tropicamide 1% eye drops

What taking part involves

  • • This is not a treatment trial — it collects information for a database
  • • Blood tests, including genetic testing, with samples stored for future research
  • • Brain MRI scan
  • • Amyloid and tau PET brain scans
  • • Memory and thinking tests
  • • Optional sub-study: phone calls every 3 months, yearly clinic visits, and yearly amyloid and tau PET scans

Time commitment: Taking part involves screening visits, blood samples, memory tests, an MRI scan and PET scans within the first few months; a sub-study adds 3-monthly phone calls and annual clinic visits with yearly PET scans — total study duration: Not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
60 Years to 90 Years
Who
All
Number of participants
1,200
Started
2024-09-26
Last checked
2026-04

Plain English Summary

What is this study?

  • • Testing a new treatment for mild cognitive impairment
  • • Clinical study - 1,200 participants
  • • Bio-Hermes-002 is a 120-day cross-sectional study that will result in a blood, CSF, retinal, digital, MRI, and PET brain imaging biomarker database that can be used to determine the primary objective

Who can take part?

  • • Ages 60 Years to 90 Years
  • • Diagnosed with mild cognitive impairment

Where?

  • • Motherwell - NeuroClin Glasgow
  • • London - Re:Cognition Health
  • • London - Dementia Research Centre, UCLH

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

Bio-Hermes-002 is a 120-day cross-sectional study that will result in a blood, CSF, retinal, digital, MRI, and PET brain imaging biomarker database that can be used to determine the primary objective. Digital biomarkers and blood-based biomarkers will be tested to determine whether a meaningful relationship exists between biomarkers alone or in combination with tau or amyloid brain pathology identified through PET images.

Mild Cognitive ImpairmentAlzheimer's DiseaseAlzheimer's Disease, Early OnsetMemory LossMemory DisordersMemory Impairment

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 60 Years - 90 Years
  • Who can join: All genders

Biomarkers mentioned

known negative

Treatment history

Treatments you must have had:

  • ✓ a Mini-Mental State Exam (MMSE) score of 16 to 30 inclusive at screening

What the study is looking for

  • ✓Pre-screening Inclusion Criteria
  • ✓Participants must meet ALL of the following criteria to progress to Visit 1 (Screening):
  • ✓Participant is between 60 to 90 years of age (inclusive) at the time of consent; and
  • ✓Core Study Inclusion Criteria
  • ✓Participants must be willing to undergo an MRI brain scan within 90 days and an amyloid and tau PET scan within 120...

Who cannot take part

  • ✗Pre-screening Exclusion Criteria
  • ✗Participants who meet ANY of the following criteria will not be eligible to progress to Visit 1 (Screening):
  • ✗Participants who have reported or have a known negative amyloid PET scan in the past 6 months;
  • ✗Participants with any known safety concern to brain MRI scan;
  • ✗Participants with history of stroke or seizures within 1 year of the Pre-Screening Visit;
See the full criteria
Inclusion Criteria: Pre-screening Inclusion Criteria Participants must meet ALL of the following criteria to progress to Visit 1 (Screening): 1. Participant is between 60 to 90 years of age (inclusive) at the time of consent; and 2. Participant has a study partner who has sufficient and frequent contact with the participant (defined as at least 8 hours of contact a week) and is able to provide accurate information regarding the participant's cognitive and functional abilities. Core Study Inclusion Criteria Participants must meet ALL of the following criteria, in addition to the Pre-screening Inclusion Criteria, for entry into the study: 1. Participants must provide written consent in the IRB-approved or Ethics Committee (EC) approved informed consent form or have a legally authorized representative (LAR) provide written consent on the participant's behalf in accordance with local and national guidance and regulation; 2. Participants must be willing to undergo an MRI brain scan within 90 days and an amyloid and tau PET scan within 120 days of signing informed consent; 3. Participants must be willing to comply with all study procedures as outlined in the informed consent, including blood sampling, genetic testing, and storage of biospecimens for future research; 4. Fluency in the language of the tests used at the study site; 5. Participants must be willing to be contacted for possible participation in clinical research trials once their participation in this study ends; and 6. Participants must have a Mini-Mental State Exam (MMSE) score of 16 to 30 inclusive at screening. Exclusion Criteria: Pre-screening Exclusion Criteria Participants who meet ANY of the following criteria will not be eligible to progress to Visit 1 (Screening): 1. Participant is unable to undergo amyloid and tau PET scans due to self-reported pregnancy, sensitivity to ligands being used, poor venous access, contraindication to PET, or planned or recent exposure to ionizing radiation that in combination with the planned administration of amyloid radioligand would result in a cumulative exposure that exceeds recommended local guidelines; 2. Participants who have reported or have a known negative amyloid PET scan in the past 6 months; 3. Participants with any known contraindication to brain MRI scan; 4. Participants with history of stroke or seizures within 1 year of the Pre-Screening Visit; 5. Participants with history of cancer within the past 5 years with the exception of non-melanoma skin cancer or prostate cancer in situ; 6. Participants with known or suspected alcohol or drug abuse or dependence within 1 year of the Pre- Screening Visit; 7. Participants who report any current unstable psychiatric symptoms that could interfere with study procedures or impact study data (e.g., uncontrolled depression); 8. Participants who have received any potential disease modifying AD treatment within 6 months prior to the Pre-screening Visit; and 9. Participants with known history or self-report to be Human Immunodeficiency Virus (HIV) Positive unless controlled by antiviral medication. Core Study Exclusion Criteria Participants who meet ANY of the following criteria, in addition to the Pre-screening Exclusion Criteria, will not be eligible to enroll into the study: 1. Participants who, in the opinion of the Site Principal Investigator, have serious or unstable medical conditions that would prohibit their completion of all study procedures and data collection; 2. Participants who have serious or unstable medical conditions that would likely preclude their participation in an interventional research trial; 3. Participants with self-reported, untreated conditions such as vitamin B12 or folate deficiency or bladder infections that in the opinion of the Site Principal Investigator could contribute to cognitive impairment; 4. Participants who have completed cognitive testing within 1 month of Visit 1 (Screening) where the Site Principal Investigator believes the participant's exposure may cause practice effect; 5. Participants who have any neurological disorder affecting the central nervous system, other than AD, that may be contributing to cognitive impairment (e.g., Parkinson's disease, other dementias, multiple concussions or seizures) as deemed significant by the Site Principal Investigator; 6. Participants with a Geriatric Depression Scale (GDS) score greater than or equal to 8 at Visit 1 (Screening) and is deemed to be clinically significantly depressed by the Site Principal Investigator; 7. Participants with a Rey Auditory Verbal Learning Test (RAVLT) t-score of ≥ 1.2 standard deviation above the mean. For non-African Americans, calculate age-sex-education adjusted t-scores. For African American participants, use the MOANS to calculate the age-education adjusted t-scores; 8. Participants weighing less than 110 pounds; 9. Participants who are direct employees or family members of direct employees of the participating investigators' sites; 10. Participants who are direct employees of the Sponsor; 11. Participants who, in the opinion of the investigator, are unable to complete cognitive testing due to inadequate visual or auditory acuity; and 12. For participants completing the RetiSpec retinal scan: Those with a known history of contraindication or allergy to Tropicamide 1% (pupil dilation drop). Longitudinal Sub-Study Eligibility Inclusion Criteria: Participants must meet ALL of the following criteria for entry into the sub-study: 1. Participants who completed the Bio-Hermes-002 Core Study; 2. Are willing to complete phone call visits with site staff every three months and return to the clinic for an annual evaluation; and 3. Are willing to complete annual PET scans for both amyloid and tau scans. Exclusion Criteria: Participants who meet ANY of the following criteria will not be eligible for entry into the sub-study: 1. Those who are enrolled or intend to enroll into a clinical trial for Alzheimer's disease with a potential disease-modifying intervention; 2. Participants who have serious or unstable medical conditions that would likely preclude their participation in an interventional research trial; 3. Those who intend to use medications outside clinical research studies approved by regulatory authorities to modify Alzheimer's disease pathology.

Where Is This Study? (3 UK sites)

NeuroClin Glasgow

Motherwell ML1 4UF, United Kingdom

Recruiting
Site contact (verified)
Jennifer Lynch, MDPrincipal Investigator

Re:Cognition Health

London W1G 8TA, United Kingdom

Recruiting
Site contact (verified)
Emer Macsweeney, MDPrincipal Investigator

Dementia Research Centre, UCLH

London WC1N 3BG, United Kingdom

Recruiting
Site contact (verified)
Catherine Mummery, MDPrincipal Investigator

How to Get in Touch

Amanda Ng, MA

Sponsor contact

CONTACT

biohermes-002@globalalzplatfor biohermes-002@globalalzplatform.org
Data sourced from ClinicalTrials.gov · Last verified: 2026-04